What is genetic testing able to do and not do with current services? We talk with one of the top genetic lab services to understand how technologies differ in accuracy and where it is working, where it is not yet ready and why.

In this episode we look at the impact that genetics has on our health and wellness. With rapid discoveries in epigenetics, the picture isn’t as clear as when we thought genetics was everything. Epigenetic factors regulate which parts of our genetic blueprints are actually active and working for us at a given time.

As previously covered throughout this show, the typical “cookie cutter” approach to genetic testing often doesn’t lead to results. We look at the potential for genetics to give us precision medicine and precision health, where people get targeted advice and care fit for individual needs. You are an individual; you are an n=1 experiment.

In which areas does modern day genetic testing give actionable information? For instance, what drugs should you use? What diet may best fit you? Which health complications are you most at risk for in the long term – so that you can strategically manage these and put the effort in where it’s really going to count for you?

We put a team together to really go after genetics as a solution for patients, and using genetics and genomics as a solution for patients, and also physicians, for risk assessment or to give them insight into personal issues and to try and take some action against it.
– Michael Nova

Today’s guest is Dr. Michael Nova. He is Chief Innovation Officer and Founding Executive at Pathway Genomics. The company is an accredited clinical laboratory that offers genetic testing services from screening for cancer and other disease predispositions – to precision health and medicine advice. These services differ and are broader than those of 23andMe, which you probably know about as you listen to this show – that’s the genetic testing company that most people have heard of and used.

Pathway Genomics is the first company to bridge artificial intelligence and genetics-based precision medicine or a health mobile app to consumers. It does this in partnership with IBM, and notably IBM Watson which is IBM’s artificial intelligence machine learning platform.

Dr. Nova is the inventor of many of Pathway Genomics’ solutions. He has over 30 patents and many studies published in peer-reviewed journals. He is also a winner of the World Economic Forum Technology Pioneer Award. Finally, he’s a serial entrepreneur and is on the board of advisors for IBM, which is a pretty big deal.

I hope you enjoy this interview with Dr. Michael Nova and it helps you to understand how genetics can be valuable to you personally.

The episode highlights, biomarkers, and links to the apps, devices and labs and everything else mentioned are below. Enjoy the show and let me know what you think in the comments!

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What You’ll Learn

  • Dr. Nova’s roots in genetics and how Pathway Genomics differs from 23andMe in structure, technology, staff, and interpreting testing results (06:12).
  • Why reporting on genetic tests varies between companies; why testing does not produce ‘black and white’ interpretations of tested parameters (15:22).
  • The meaning of personalized / precision medicine; current applicability and future prospects, as numerous testing technologies become cheaper (17:46).
  • How genetic test panels are researched and converted into actionable information for physicians and individuals (20:40).
  • The complexity of genetic and epigenetic tests and why professional guidance is required when making health decisions based on results (29:30).
  • Why epigenetics is more complex than genetics and how genes are switched on / off by interactions with the environment or due to behavior (33:50).
  • Pathway Genomics and IBM’s Watson collaboration – integrating extremely diverse and data-dense medical information into meaningful outputs (36:11).
  • How genetic testing improves pharmacological prescription decisions and why increasingly complex data is even more useful (39:20).
  • Optimizing exercise for individuals using genetic information (46:04).
  • How to access information about personalized medicine and genetic testing (47:33).
  • What information Dr. Nova tracks on himself and why it is crucial to be aware of your genetics (49:46).

Thank Michael Nova on Twitter for this interview.
Click Here to let him know you enjoyed the show!

Michael Nova, Pathway Genomics

Tools & Tactics

Diet & Nutrition

  • Mediterranean Diet: All diet recommendations at Pathway Genomics are generated based on a Mediterranean diet. Based on personal genetic information, diets can be modified towards a low-carbohydrate or low-fat diet.

Tracking

Biomarkers

  • BRCA genes: There are two BRCA genes, BRCA 1 and 2. Certain mutations in these genes are associated with a high risk for developing breast and/or ovarian cancer. Full gene sequencing and results interpretation is offered by the Pathway Genomics BRCATRUE test. Angelina Jolie underwent preventative breast surgery because of her positive BRCA 1&2 status and her family history with breast cancer.
  • Maximal Oxygen Consumption (VO2 max): The maximum rate of oxygen consumption as measured during exercise, usually on a motorized treadmill. VO2 max reflects the aerobic physical fitness of an individual. The Pathway Genomics PathwayFit test includes sequencing of genes which are relevant to VO2 max in individuals.

Lab Tests, Devices and Apps

  • Pathway Panorama (Not Yet Available): This will be a genetics-oriented mobile health application. It is intended to integrate personal genetics with publicly available scientific medical information from trusted sources. Using the IBM Watson engine, the app will compare this information to the standard of care and provide personalized feedback on health and well-being.
  • Fitbit Charge: Fitness watch with automatic monitoring.
  • Pathway Genomics: Genetic Testing Panels

  • BRCATrue: A genetic test that searches for mutations in BRCA1 and BRCA2 genes.
  • PathwayFit: Analyzes over 75 genetic markers known to impact metabolism, exercise, and energy use within the human body. Provides insight into how your body may process sugars, fats, nutrients, and vitamins. This is the most popular test of Pathway Genomics.
  • Healthy Weight DNA Insight: One of the most comprehensive weight-related genetic tests available. Unique combination of nutrigenetic, medication, and general health information.
  • Mental Health DNA Insight: Identifies genetic variants that affect the metabolism and efficacy of psychiatric medications. More than 30 common antidepressants, mood stabilizers and antipsychotic medications included.
  • Pain Medication DNA Insight: Identifies genetic variants that affect how an individual will respond to the analgesic effects of certain types of commonly prescribed pain medications.
  • Cardiac DNA Insight: Tests for the genetic risk of a variety of heart-related health conditions. Examines eight classes of drugs that affect the cardiovascular system.
  • Genetic Testing Technology Platforms

  • Fluidigm Assays: Pathway Genomics uses Fluidigm assays with high precision and whole gene sequencing to detect ALL Single Nucleotide Polymorphisms (SNPs). These are variations in DNA code which are usually associated with predispositions towards health-related conditions. In comparison, the company 23andMe does not use Fluidigm technology.
  • Illumina Chip Seq Assays: In addition to Fluidigm technology, Pathway Genomics uses this technological platform for genetic testing. The company 23andMe also uses this type of genetic testing technology.

Other People, Books & Resources

People

  • Prof. Roger Guillemin: Dr. Nova started his career in genetic at the laboratory of Prof. Guillemin – who was awarded the 1977 Nobel Prize for Physiology or Medicine for his work with hypothalamic hormones.
  • Jim Plante: Founder of Pathway Genomics.
  • Eric Topol: An American cardiologist, geneticist, and digital medicine researcher. Mr. Topol is a leading voice in the field of personalized medicine and putting the consumer in charge of his/her own healthcare.

Organizations

  • IBM Watson Health: Overview of healthcare applicability of the IBM Watson’ artificial intelligence platform.
  • 23andMe genetic testing A popular and accessible genetics testing service company. The 23andMe model is focused on testing for subsets of SNPs (Single Nucleotide Polymorphisms) across various genes.
  • GeneMed: The company provides cancer and infectious disease diagnostic reagents for different instruments and technology platforms. This company also provides development and commercialization services to partners for improving In Vitro Diagnostic (IVD) products.
  • Lab Corp: Laboratory Corporation of America provides lab testing and services, with expertise in esoteric testing, genomics, and clinical and anatomic pathology.

Other


Full Interview Transcript

Click Here to Read Transcript

(06:12)[DAMIEN BLENKINSOPP]: Michael, great to have you on the show.

[MICHAEL NOVA]: Thank you, it’s my pleasure.

[DAMIEN BLENKINSOPP]: How did you first get into the area of genomics, and now it’s personalized medicine, but was there an evolution towards that? When did this first start for you?

[MICHAEL NOVA]: I was a research associate at the Salk institute a while back in a Nobel Prize winner’s laboratory – his name was Roger Guillemin. It was a very large laboratory; it had a lot of different technologies and scientists that were involved with it, as you can imagine.

The overall function of the laboratory was to study growth factors, and so we were studying everything about growth factors. We were studying how the proteins worked, tissue culture, how they interacted with each other, the DNA and RNA genetics of these growth factors, everything you could think of.

[DAMIEN BLENKINSOPP]: When you say growth factors, what exactly would that be for?

[MICHAEL NOVA]: Things like human growth hormone and thyroid releasing hormone and corticotropin-releasing factor, every kind of growth factor.

[DAMIEN BLENKINSOPP]: Okay. Things that stimulate growth in the human body?

[MICHAEL NOVA]: Yeah, in one way or another. He got the Nobel Prize for the first person to isolate TRF, which was a growth factor that was released in the hypothalamus. A signal that is released in the hypothalamus goes to the pituitary and then turns on all these thyroid hormones. That’s what he got it for, and so we were just peeling back the onion on a lot of different growth factors using different technologies.

I got into genetics there and then I started a couple of companies and took one public in the biotech area. We’ve almost used genetics as part of the technology, but it’s only been recently when we started (with Jim Plante, the founder of Pathway Genomics), we put a team together to really go after genetics as a solution for patients, and using genetics and genomics, I guess, as a solution for patients, and also physicians, for risk assessment or to give them insight into personal issues and to try and take some action against it.

I think it’s really been within the last ten years that the technology has been inexpensive enough that we could even try to use it directly for patients.

[DAMIEN BLENKINSOPP]: Great. First of all, I think a lot of people have heard of 23andMe, but they haven’t necessarily heard of Pathway Genomics, so could you give us a comparison of how the technologies compare and how the service is different? I know Pathway Genomics kind of evolved over time, so potentially a bit of that back story would be helpful too.

[MICHAEL NOVA]: Sure. First of all, the major difference is we have our own laboratory; 23andMe doesn’t. We have a big laboratory staff and scientific staff and curators and all that. All the tests come back to our laboratory and we do the DNA isolation and we do the reading of the mutations on different types of machines and then develop a report that goes back to the physician, which is the second difference: we’re only a physician’s ordered test; we’re not direct to consumer. So there has to be a physician in the loop or some kind of health provider in the loop, certainly on the ordering side, but also on the interpretation of the test.

All our tests are covered by insurance in the United States – that’s a third differentiator. We sell our tests in 44 different countries…

[DAMIEN BLENKINSOPP]: So just on the insurance angle; I understand it that you’re targeting a much smaller range of genetics, and basically you’re targeting specific arrays of things that you want to look at, like pharmacogenetics and other areas of the human body, whereas 23andMe is very, very broad in terms of what they look for?

[MICHAEL NOVA]: Yeah that was going to be my fourth!

[DAMIEN BLENKINSOPP]: Oh sorry.

[MICHAEL NOVA]: You took the wind out of my sails with that one, that was going to be the fourth big differentiator. We offer, like you said, panels of genes. We have a test for fit, nutrition and exercise, which only covers those two elements and then some eating behaviors and some metabolism.

Then we have another test for pharmacogenetics, like you mentioned. And one which is specifically for psychiatric, and another one that’s specifically for pain medications. Then we have a cardiovascular test, a cardiovascular risk, which also has some diet and exercise components in it.

So we have about 12 different product lines, 12 different types of tests, including BRCA. We do whole genome sequencing or next generation sequencing for the entire BRCA gene, if you know that gene. It’s the one that is prominent in certain ethnic groups for hereditary breast cancer. It’s the same gene that Angelina Jolie had. So we test for that as well.

We’re the only comprehensive genetic testing company that has health and wellness products all the way to hardcore next generation sequencing products for risk assessment for things like breast cancer.

A new thing that’s coming is we have an alliance with IBM, who’s an equity partner, and we’re building a mobile application that will basically put an artificial intelligence super computer in a handset to help with managing patient information and giving recommendations back directly to the user. That will be a direct to consumer type of product, but at this point we don’t sell any of our genetic tests direct to consumer.

[DAMIEN BLENKINSOPP]: I’d like to take a little step back because 23andMe and you are really very different propositions. There’s also the technology and the accuracy of the tests, and you have a different price point as well. Whereas I think for 23andMe for the whole thing right now, it’s $99; per array, yours is roughly $199 per different panel. So why is that, what’s the difference in the technology and what you’re delivering?

[MICHAEL NOVA]: It depends on the genetic tests. We do Fluidigm assays for our smaller arrays of up to about 80 different genes; 23andMe doesn’t do that. They basically take an Illumina chip that’s got a certain number of markers on it and run that chip for their $99 test. We also have that chip-based technology and then we also have the sequencing technology, which 23andMe doesn’t have.

So we have, the sequencing technology is basically more expensive than the Fluidigm or TaqMan assays, which are probably the least expensive.

We run every different type of genetic testing in here, but some of our reports require more than one platform. Some of them require the Fluidigm platform plus either maybe a sequencing or plus an Illumina chip, so the cost varies on a particular report based number one, on the technology that we’re using – it could be more expensive to run that particular report.

Then the way we do the reports is also different. We have a physician that reviews the results, we have a dietician that reviews the results, we have all those people that are on staff that are patient and can access at any time, so there’s a little bit more cost that’s embedded into the test or tests, depending on which one the clinician orders from us.

[DAMIEN BLENKINSOPP]: Right. Are your tests 100% accurate, so we could run them one time and we’d know for sure which gene SNPs we have?

[MICHAEL NOVA]: Sure. We have our own laboratory and it’s CLIA certified, CAP certified, it’s New York State certified. We’re the only comprehensive genetic testing company that has a health and wellness panel that’s been certified by New York State, which is very difficult to get.

23andMe can’t sell in New York State; they can’t sell in certain countries because direct to consumers is illegal. It’s illegal in places like Brazil and Singapore.

Our accuracy, since we’re licensed by three or four different licensing bodies, they come in here and inspect us all the time, at least once a year on all of them. So, we have to be extremely accurate.

[DAMIEN BLENKINSOPP]: I guess what I’m getting at also is the chip set that 23andMe is using is pretty reliable but it’s not 100% accurate, as I understand it. So in the past when I’ve done tests – I’ve done the 23andMe and I’ve done some other more specific genetics tests – and the answers weren’t the same. As I understood it, it was related to the technology that 23andMe uses, which is very economical to get a lot of data – which is interesting, so look at a variety of risks – but if you want to actually get clinical based information where you’re going to make decisions, you should run with the sequencing technology that you’re using with your panels to be 100% certain. Or am I looking at the wrong things there?

[MICHAEL NOVA]: No, I think you’re right on one aspect or a couple of aspects of what you said. I think that for things like the BRCA test, which is a very serious type of genetic test, 23andMe only reports on a couple of variants on the BRCA mutations, whereas we run the entire sequence. So the doctors come to us for that particular test; they would not necessarily go to 23andMe, even though the mutations that they provide and the way they do it are probably accurate, but they, just by definition, miss stuff.

It doesn’t mean that their technology is bad, which it isn’t; it doesn’t mean that the way they run the Illumina chip is not sufficient. That’s not correct. For what they’re reporting on, it’s perfectly adequate.

[DAMIEN BLENKINSOPP]: So everything you get reported should be correct with their technology as well – the Illumina chip?

[MICHAEL NOVA]: Yeah and I think it’s a good company. 23andMe is a good company. There are good companies like us and 23andMe and some of the other ones – we’ve been at this for eight years or seven years; we know what we’re doing. We just happen to have our own laboratory and so we’re under a lot of different kinds of governance that 23andMe isn’t under.

(15:22)[DAMIEN BLENKINSOPP]: Do you use blood samples as well, or is it saliva samples?

[MICHAEL NOVA]: Sure, we can use blood, saliva…

[DAMIEN BLENKINSOPP]: Is there a difference in the quality, or is it exactly the same, it doesn’t really matter which one you use?

[MICHAEL NOVA]: Both samples have different pluses and minuses, but trying to get to the same endpoint you still have to conform to what the governing bodies and what the licensing groups want us to report on. So we don’t have any choice but to make them equal in the end – if you gave us a blood sample or a saliva sample. But the way we do each one… in some respects it’s harder to do saliva because there are more contaminants in it and whatever, but then it’s a much easier test. People don’t necessarily want to get needle stick all the time.

[DAMIEN BLENKINSOPP]: I guess I’m trying to understand like I had a blood test run through DNA sequencing and a couple of the SNPs were different compared to my 23andMe. What would be the cause of that or is it a mystery?

[MICHAEL NOVA]: We can’t do that necessarily. We would certainly have to report on the same SNPs in the report in the same way so I don’t know. It could be a number of different things.

23andMe, again, has been around for a long time and so I think the accuracy of their reports and what they’re reporting on is really good. It’s hard for me to make a kind of black or white decision on something like that.

[DAMIEN BLENKINSOPP]: No, no, I’m not talking black or white, I’m just curious if there was a technological basis or something like that.

[MICHAEL NOVA]: There might be.

[DAMIEN BLENKINSOPP]: Yeah, I just figured it was the slightly different configuration of the technology.

[MICHAEL NOVA]: I’ll give you a really good example here and I think people don’t realize it: If you went and got a SMAT panel or a CAM panel from one company, like LabCorp, or you went and got one and put in the same sample to Quest, there’s no question that there will be a little bit of difference in what each one of these things reported on, but just a tiny bit of difference. That doesn’t mean that they’re wrong – either of them.

People think that genetics is black and white and the laboratory results are exactly 100% supposed to be the same all the time; that’s not necessarily true. And then we don’t know a lot more about the genetics either: There are 25,000 different genes, and we probably know what about 10,000 of them actually really do, but then they have to work with each other and all this kind of stuff.

I think getting the information on the particular SNPs is not necessarily the hard part; the hard part is interpreting what it means and giving that information back to the patient.

[DAMIEN BLENKINSOPP]: So it may be just a different reporting basis, that’s what it sounds like.

[MICHAEL NOVA]: Yeah, it could be.

(17:46)[DAMIEN BLENKINSOPP]: Taking a little step back, because I know this is basically your area, what does a shift to personalized or precision medicine and health mean versus where we are currently in the world?

[MICHAEL NOVA]: As a physician, we’ve always kind of practiced personalized medicine. When somebody comes in and they’ve got some condition they’re worried about, we give them their medications or help based on them as a person. But now, we’ve got a lot more tools. There’s a lot more granularity in what we can actually see that might be affecting this individual or even preventing things from happening.

Genetics is just one of those tools. So there’s genetics, there’s epigenetics, there’s transcriptomics, there’s all these different types of technologies now that are becoming less and less expensive. They’re kind of getting weaved into the management, if you will, of patients, and that’s what doctors are doing, basically, with our reports.

Precision medicine is just another name for personalized medicine, but I think one of the reasons there’s a much bigger push for it now is that we’re really seeing some major advances in cancer-targeted therapies using genetics, we know cancer is a genetic disease, a molecular disease. We’re now starting to target individual mutations in these cancers to give better results.

We’re now getting a clearer understanding of things like obesity – there are 97 genes that are related to obesity – they’re all different metabolites. It’s not necessarily going to be one size fits all and now we just have technologies that are getting less and less expensive to weave in information for the physicians to make decisions on. That’s where it’s at right now.

This is going to be an ongoing process forever; there’s going to be some sort of genetics or -omics or precision medicine technology that we’ll be able to use to really personalize individual therapies or prevention regimes or whatever you want to call it.

b>[DAMIEN BLENKINSOPP]: I guess one of the things about personalized is, if we take a comparison: If you have a cough today, you’re given the same drug no matter who you are; but in the future – and you have a panel which is pharmacokinetics – you could look at the impact of the drug on you – depending on your genes, drugs have a different impact. So it’s taking it up to a much more personalized level than what is possible today by just looking at someone.

In some cases, maybe you’ll see they’re different and maybe have got some blood test that is slightly different, but the genetics adds another layer of personalization.

[MICHAEL NOVA]: This is standard knowledge in the industry that anywhere between 40 and 50% of all drugs that are prescribed fail for the user, and especially the first time around. That’s a huge number.
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If we can add some way of tailoring those drugs – maybe you take this antidepressant instead of that antidepressant or you take this cough drug versus some other cough drug because your liver is metabolizing it different based on your genetics – you’re more likely to get a much better result.

Again, that is certainly where everything is headed in this whole precision medicine area.

(20:40)[DAMIEN BLENKINSOPP]: Great. So I also just wanted to talk to you – your tests are insured compared to the other ones, so I guess that the extent of research done on the specific panels is quite deep to get to that level where now tests can be insured.

[MICHAEL NOVA]: Yeah it depends. I’ll just take Medicare as an example because they’re kind of the gatekeeper for insurance coverage and our tests are covered by Medicare. The way that Medicare does it now in the United States, it looks at a panel on a gene by gene basis, and some genes have more clearly defined outcomes and predictability than others. So, on a panel of 80 genes, they might only cover three or four of them, but that’s enough to cover the entire cost of the panel.

There are three big levels of gene coverage in America. There’s a) genes that are covered automatically, like methylenetetrahydrofolate and some of the genes for warfarin metabolism. These are covered automatically, it’s an automatic payment, and since the technology on the panel is cheap enough, at least for us, to get over the cost of doing just that one gene, whatever Medicare decides to pay us, we make enough money to cover the panel. That goes for all the other insurance companies too, whether it’s United Healthcare pays on certain things, Aetna pays on certain things. Some insurance companies don’t pay at all on genetics, one way or another, so it really is not just based on whether the data is good enough, but it’s also based on whether a certain insurance company thinks it’s relevant enough to pay for it.

[DAMIEN BLENKINSOPP]: Right, right. As you’re saying, only part of your panel will necessarily be covered by that, and then there’s other things you’ve added, which you feel are relevant too. How’d you make those decisions? What kind of level of research has to be done?

[MICHAEL NOVA]: Yeah. We have a very strong curation. We have, I think, 15 PhD level geneticists and genetic counselors, and myself and a number of MDs, and we basically go and we grind through the literature. We look for human clinical studies and see if the data is relevant enough or there’s enough human clinical studies to put the gene into the panel and then report on it. We can only report on what the human clinical studies tell us.

There are plenty of genes and plenty of studies out there that we never would report on because we don’t think it’s relative; we don’t think that the data is strong enough. So to give you an example, in our healthy weight and fit test – which is our most popular test by far – we rate the science level in the test.

A really good clinical scientific study, let’s say on thousands of patients, and it has to be replicated in the same ethnic group, showed the same results and hopefully over multiple times, then that gets four stars.

Then there are other studies that aren’t quite as well validated but we think that there’s relevance because it might only have been done in two or three clinical studies of 500 patients each, which isn’t necessary a thousand patients but it’s 500 and it does show the same phenotype or it does show the same direction for what the genetics is reporting on. That’s a pretty good study so that gets put in the test too.

[DAMIEN BLENKINSOPP]: Great. I was going to actually ask you which was your most popular test but you’ve already brought it up.

So in terms of what that test gives people, who’s asking for the test and in what conditions are physicians looking for this kind of test? Is it someone who’s had a recurrent obesity problem for a very long time? What are the kinds of conditions and what’s actionable about that information for the physician once he gets it?

[MICHAEL NOVA]: For that particular test, we have a lot of different types of physicians that order it. Some are obviously looking for weight management, weight control in their population. But we also have people that are diabetics that are trying to use it to control their sugar levels or hemoglobin A1c levels, so we have a whole group of anti-diabetic groups that are using the test.

We have cardiovascular groups: many cardiologists think that most cardiovascular disease can be prevented by diet and exercise changing, so we have a lot of cardiologists that order the test and try to put people on more balanced types of diets, more personalized types of diets. Not necessarily to lose weight but to cut down lipid levels and other things that cardiologists worry about.

Then we have performance groups: we have performance athletes, we have gyms like Equinox health clubs that order our tests for a lot of their gym members to either increase performance or put on muscle mass, depending on what exercise.

So basically we have a lot of different types of groups, not just one type of clinician or group that orders the test.

[DAMIEN BLENKINSOPP]: Great. Is there an example you could walk us through of one of the most actionable genes in that area which people look at?

[MICHAEL NOVA]: Well, on that particular test… or do you mean all our tests?

[DAMIEN BLENKINSOPP]: The most popular one, because you said this was the most popular, if there’s one specific gene that people watch out for more than others.

[MICHAEL NOVA]: I don’t think it’s one particular gene. There are about 80 genes that we report on and we chop up the test into basically seven different sections. One section has to do with what is the best diet for you if you’re trying to lose weight and we have four different diets. That’s based on 50 different genes and how they interact with each other. Then we give you a diet recommendation, whether it’s low-carb, low-fat, standard Mediterranean or balanced diet. All of our diets are based on Mediterranean, but some have lower carbohydrates than others; some have lower fats.

Then we also give diet plans along with. So that’s a very popular part of the test, that section.

Another popular part of the test is we have a behavioral section, which looks at things like eating disinhibition – “I can’t stop eating.” Those genes around “When I start eating, I can’t stop eating.” Those genes in your dopamine pathway. We look at sugars – “Do I have a sweet tooth? Do I tend to like sugars more?” So this whole behavioral section is a very popular chunk of the test as well.

Then we have a standard metabolism section – we look at things like do you have a tendency to have increased insulin? Do you have a tendency to have increased lipid levels? Those types of genes, and there are multiple genes in that section – 20 or 30 genes in that section, so that’s also a popular part of the test.

[DAMIEN BLENKINSOPP]: Right. One of the interesting scenarios I think is the diet, the high fat versus the low-carb and the low-fat. Because a lot of the dietary recommendations today, it’s basically which crowd do you want to go with? I’m with the low-carb crowd; I’m with the high fat crowd, high protein…

Some of the genes can be pretty significant in that area, like the APOE gene. Could you talk a little bit about that and how that influences your diet and whether fats are going to be good for you or are basically going to be problematic.

[MICHAEL NOVA]: Let’s go back and look at diets in general. Most people, if they got on a diet and it was less calories than they usually intake and they stayed on that diet for years, they would probably lose weight. But it’s very difficult to get people to do that for a number of reasons.

So what we try to do is we try to look at particular genetics around fat metabolism – and APOE is one of them, and PPARgamma, and even FTO and some of these other genes – and not only how you process fats but also how you taste things. You have bitter taste receptors that we look at.

People don’t eat things that they don’t like, so we try to tailor the diet based on a number of these big subsets, whether it’s how you metabolize lipids – and people that have two copies of the FTO gene, there’s no question that they have trouble metabolizing fat in a low carbohydrate diet than somebody that doesn’t have those. That gene has been very well characterized and is a known obesogenic gene along with MCR4. If you put those two genes together, people that have those two genes tend to be about ten pounds overweight than people that don’t have them.

So we take that information, then we go back and we design a diet that’s based around not only what your metabolism is but also what you potentially would like to eat and make it a diet that isn’t too rigorous, that you’ll never stay on, and then try to give you direct diet plans – basically what to eat, literally, on a daily basis: Breakfast, lunch and dinner, this is what you should eat.

Then we have diet specialists and nutritionists and exercise physiologists and all that stuff, that if you really need help with that kind of stuff, we have ways to get you that as well.

I guess what I’m getting at is we don’t like to look at genetics in a vacuum. It’s one part of a big puzzle, and the more pieces of the puzzle we can put together, the more success we have for personalizing things for the user. That seems to really work.

We have other 20,000 physicians in the US that are ordering our tests and they keep ordering it over and over again, along with our diet plans and whatever information we give them, and the results speak for themselves – they’ve shown that what they get out for their patients is really working.

(29:30)[DAMIEN BLENKINSOPP]: Can we just go back to a distinction that you made was that you’re not doing genetics, you’re more doing genomics, right – the interaction of all of the genes together? Is that what you mean by you were saying?

[MICHAEL NOVA]: That’s a little bit of a slicing that onion really thin.

[DAMIEN BLENKINSOPP]: So what is the approach? You’re saying that it’s not a good idea to look at just one specific gene on its own?

[MICHAEL NOVA]: Yeah, very few things are one gene and then you have something bad happen. Even then, even for things like BRCA, it’s still only a relative statistic. Even if you have BRCA and you’re Ashkenazi Jewish and have the mutations that are relevant, there is still only a 80% probability that you’ll end up having breast cancer. So that means there’s 20% that you wouldn’t have breast cancer.

So very few things are one gene, one bad outcome, fortunately. It’s usually multiple genes. Again, we talked about obesity – there’s at least 80 or 90 different genes that have something to do with making somebody obese. And how they all work together? That’s the gold nugget in all this business is how to figure out how they all work together.

[DAMIEN BLENKINSOPP]: The BRCA gene is interesting because they’re pretty extreme decisions, or as you say, very rational decisions, but a lot of people see it as an extreme decision that Angelina Jolie has taken and it’s been in the press and everything.

One factor into that is that there’s genetics versus epigenetics and how we approach genetics in practice when there’s potential for some epigenetic influence and where the gene’s not actually turned on or off, right? You don’t know which one it is – is it turned on or is it turned off? Were Angelina Jolie’s BRCA genes – were they turned on and, therefore, they did represent the risk?

So, just based on what you said there, you said there was an 80% chance – I don’t know if that was a real statistic with a certain BRCA gene, but would it be in that kind of order that they were looking at BRCA?

If you took your BRCA panel, even not looking at the epigenetic influence, is there an 80% chance that that risk really exists, without taking into account the epigenetic influences?

[MICHAEL NOVA]: Correct. And remember, BRCA was first isolated in the Ashkenazi Jewish population – that’s where it’s most relevant. Angelina Jolie had family members who had breast cancer. So her decision to have surgery was based not only that she was BRCA1 and BRCA2 positive but also the fact that her mother, I think, died of breast cancer, and she’s half Ashkenazi Jewish.

So there were a number of factors that went into her decision to have surgery, not only to have her mammaries resected but also to have her ovaries taken out. I think she went down that path as well because there’s an increased risk, potentially, for ovarian cancer, which is still a very serious disease.

So you have to take all the information in total. If there was no breast cancer in her family and she wasn’t part Ashkenazi Jewish, then there might be a reason to not potentially go down that path. But that’s up to her and her clinician to work that out.

That’s why we don’t think a test like that, which is a very serious test, should ever be direct to consumer. That, for us, is something that really needs some guidance along with trying to make decisions about that.

[DAMIEN BLENKINSOPP]: Right. Excellent. I think the epigenetics area – how do you approach working with your physicians and advising them?

Do you ask them to look at factors like you were just talking about hereditary? – what’s the situation with your parents, your grandparents; other things you can look at in conjunction with some of your tests in order to capture the epigenetics? – whether something’s actually taking place or not: Do you say, “You should run these blood tests if you get these genes, and thus you could make a better decision based on that,” or do you tend to keep it to the genetics themselves?

[MICHAEL NOVA]: We tend to keep it to the genetics at this point because epigenetics is fairly new. There’s not enough data – although I do totally believe in it – in a lot of respects for us to weave that in to the process of, “You’ve got this gene but it’s not turned off.” We can do that from a technology stand point, but there’s not enough clinical data to make really informed decisions around that.

[DAMIEN BLENKINSOPP]: Right. I was talking more, at this point, as you say, epigenetics is relatively new and it’s probably quite expensive at this point for you to be integrating that type of service.

[MICHAEL NOVA]: Those kinds of expression assays – although Illumina has a methylone chip, but I don’t think it’s a clinical grade thing – it’s definitely more expensive than the genetics.

(33:50)[DAMIEN BLENKINSOPP]: I was thinking more about metabolites and lipids and things like that. So for example, we were talking about the APOE, so if your cholesterol markers are off, that would be an indicator that that gene is switched on – correct?

[MICHAEL NOVA]: Yeah, something is definitely not working correctly or you’ve got something in your diet, also, that’s not the correct diet. Maybe you’re eating too much of X, you should be eating more of Y. So there’s, again, a number of different factors – genetics, epigenetics, proteomics, metabolomics.

The metabolomics and the proteomics and looking at lipid panels, those give you a snapshot, an immediate time of day, this is what your lipid level showed. What genetics does is give you a tendency towards where potentially the lipid levels in the long run will go if you don’t take certain actions doing certain things.

[DAMIEN BLENKINSOPP]: Yeah it does. I think the area of epigenetics is potentially very confusing to people because there is this aspect of genes potentially staying switched off. Say, for instance, exercise is an important mechanism for turning off – I’m not saying this is true – but the APOE gene, right?

[MICHAEL NOVA]: There’s been data that’s shown that FTO gene for obesity can be mitigated with certain exercise and diet regimes; those are known facts. There are starting to be really hardcore data around using the environment, and epigenetics is all around using the environment – what you do in your environment to turn genes on and off – and there is data around that.

That would be one example of something that in the near future we might end up reporting on. You can change how genes are expressed by something in the environment.

[DAMIEN BLENKINSOPP]: I’m sure at this stage it’s just at a discussion level with you and colleagues and other people that you know, but how far out do you think these kinds of things are, like being able to take the next step and understanding the epigenetic aspect of it and making decisions based on that as well as just the genetics?

[MICHAEL NOVA]: Epigenetics in some respects is even more complicated than the genetics because there are so many different things that can turn genes on and off: there are methylation patterns, there are acetylation patterns, there are phosphorylation patterns, which means molecules that actually bind the DNA, or histones or whatever, and modify things and turn genes on and off.

And then there are all the microRNAs. There’s thousands of different microRNAs, the junk matter in DNA that will turn genes on and off if they’re expressed or not. So it’s extraordinarily complicated!

(36:11)[DAMIEN BLENKINSOPP]: IBM is an equity partner in Pathway Genomics?

[MICHAEL NOVA]: Yes.

[DAMIEN BLENKINSOPP]: Right. I wanted to talk about Pathway [unclear 36:16] but I think it’s also relevant to what we’re discussing right now, it being so complex and everything. Are you looking at bioinformatics and things like that potentially in the future?

[MICHAEL NOVA]: See that’s what computers are really good at. They’re good at taking noise, basically. Whereas we would look at it and not come up with any pattern; a computer’s really good at making patterns out of things. They’re not necessarily sentient, but they’re really good at taking databases and huge amounts of information and then telling you that these two things are linked together – that’s what the information is. That’s basically what we’re starting to build with IBM.

We have a very strong bioinformatics group and engineering group, and this is an artificial intelligence. Basically, it’s the Watson artificial intelligence that can play chess and was on “Jeopardy!” the show in the United States. So we have to train it.

We like to say it’s a little bit like a dog: you train the dog by lobbing it a question and seeing what answer you get back and seeing if it’s relevant. 99% of the time to start with it’s not relevant, then you have to tell it why it’s no, and go back “It should be this instead of that.”

It’s a huge process to train, especially around health care, because there’s nothing that’s more data dense than health care data. It’s not just genetic data we’re interested in; we’re interested in your electronic health record, your lab results, your wearables – your Fitbit data and all that other stuff. We want to take all that information and then compare it to the standard of care that’s what’s going to be in the Watson engine, and then give you back a recommendation that’s really personalized.

If you asked a question like, “I’ve got a nose bleed” – if you have our mobile app Panorama – “I’ve got a nose bleed, what should I do?” you would get a different answer potentially than what I would because I’ve scanned all this different information about you and compared it to what is the standard of care, and since you’re a little bit different in this gene and your latest lab result is a little bit different over there and maybe you went for a run and fell on your face, all of those bits of information are really important in order to give you a decision or some sort of recommendation about what to do.

[DAMIEN BLENKINSOPP]: Right. That sounds incredibly ambitious.

[MICHAEL NOVA]: Sure.

[DAMIEN BLENKINSOPP]: But you are going to release something relatively soon, aren’t you, so what will that be when it comes out?

[MICHAEL NOVA]: We will have public beta, sometime September to October time frame this year. We’re going through trials right now with the alpha version.

Like you said, it’s a very complicated problem because it deals with a lot of different types of data, and then getting that data so Watson can understand it, which is a whole engineering task on its own, and then getting the right information into Watson – or IBM, the super computer, the artificial intelligence – and then getting the right and curated information in there so it has the state of art in what people are thinking in terms of health care.

So you’re right, it’s extremely ambitious, and we’re really, really excited about it.

[DAMIEN BLENKINSOPP]: Yeah I can imagine. It will be fun to use it when it comes out. Is it going to be sold through iTunes or something, how’s it going to work?

[MICHAEL NOVA]: Yeah, we’ll go through the iStore and all that, and whatever Android is.

(39:20) [DAMIEN BLENKINSOPP]: Okay great. One of the other things we touched on that I wanted to get a bit deeper into because I think a lot of people don’t realize how varied this is, is pharmacogenomics.

You have several panels; it’s quite extensive the number of panels, it seems, under that area, because you have mental health areas and other areas. Is it extremely varied the impact a drug can have on each and every person? Is this very common that drugs have very different impacts per person?

[MICHAEL NOVA]: I’ll start with the panel. We have two or three different panels for pharmacogenomics. One is what you mentioned, it’s a mental health panel that has things like anti-depressants, antipsychotics, mood elevators, 30 or 40 different drugs and they each are metabolized in your liver a little bit differently.

One drug is metabolized differently to another drug, and we look at those mutations in your liver enzymes – they’re called cytochromes.

Then there are also transport proteins that have variance in how the drug is transported from the blood into the cells. There are a couple of drugs in there that have different transport kinetics. Then there are some of them also that get excreted by your kidneys, and they have a little bit different kinetics.

So we put that whole panel together on mental health based on a lot of this genetic information, or the best that we could find. Doctors use it to try and start somebody out on a drug rather than guessing what this person should have, or they’ll change a drug based on the genetics because they’ll understand why this potential drug isn’t necessarily working.

Then we have other panels. We have a pain panel, which does the same kind of thing but around pain medications – the codeines, oxycodone, morphine, tramadol, things like that – they get metabolized differently.

[DAMIEN BLENKINSOPP]: When you say metabolized, it means processed by the liver?

[MICHAEL NOVA]: Yeah, processed by the liver. There’s also transporters and uptake and excretion that are a little bit different for some of these drugs. Again, we use that information on a broad panel of different genes to tailor what potentially would be better for somebody than something else.

That kind of data is getting better. The good thing about genetics in general is that the data just gets better and better; it doesn’t get worse. It’s not like cold fusion – it’s not going to go away. It’s just going to be integrated more and more into the practice and pharmacogenetics and, obviously, drug metabolism is a huge deal.

To give you a good example: in the Asian population, there’s a drug called carbamazepine and it’s used as an anticonvulsant. There are genes involved around the metabolism of carbamazepine that if you have these particular genes, you will probably have a very high likelihood of going into Stevens-Johnson Syndrome if you take carbamazepine, and that’s a very serious disease.

[DAMIEN BLENKINSOPP]: Stevens-Johnson Syndrome; could you just describe the effects of that because I don’t think it’s very common but it’s pretty horrific, right?

[MICHAEL NOVA]: Yeah, it’s an allergic reaction basically, an immune reaction against this particular drug and you can basically end up dying from it – you go into anaphylactic shock and your skin starts to slough off. It’s a really nasty way to go if you want to call it that way. But again, it’s not very common.

But it is common more in Asians, and so screening for carbamazepine is 100% done in South-East Asia, Taiwan, places like that that are still using the drug as part of an anticonvulsant regime. They won’t put anybody on it if that person comes up with that particular variant.

That’s a really good example of how using a genetic test will really literally dial out a lot of drugs or dial in a drug based on your genetics.

[DAMIEN BLENKINSOPP]: Right. Currently though today, it’s a little bit of a trial and error process if you see a physician. Even with antibiotics sometimes, unless you’ve had tests done, it’s trial and error. We’re working hopefully towards a place where there won’t be any of that trial and error, it will be eliminated over time by these kinds of tests.

With the caveat that epigenetics sometimes will have some influence, so it’s not 100% fallible. In terms of the pharmacogenomics, there’s still some potential that basically says “This drugs better than this one for you”. It’s not 100% fallible, correct?

[MICHAEL NOVA]: No. Again, what we try to do in the genetics business is report on what the literature tells us – period; that’s the bottom line – and is that result valid.

We know, in pharmacogenetics, that across all drugs, 40 to 50% of them fail when they’re first given, so that’s a huge problem. So, dialing in the right drug, even though it might not be 100% correct… although the Stevens-Johnson issue, with this particular gene and carbamazepine, is almost 100%, so there’s nobody in their right mind if they knew that that patient had those particular genes would put somebody on carbamazepine because that’s one of those issues that is almost really one gene, one effect – you just don’t do it!

[DAMIEN BLENKINSOPP]: Yeah, right, when the risk is so high. What other high risk ones are there? Is warfarin a big one?

[MICHAEL NOVA]: Yeah warfarin potentially could be a big one for a couple of reasons. A dosing of warfarin to begin with is a little bit difficult, you have to have really strong expertise in doing that. The way it’s done is it’s done over a period of time to figure out what your INR is and how you’re metabolizing it and then getting the right dose.

Warfarin is a serious compound; you don’t want to mess around with it. It’s basically rat poison and it’s a very serious anticoagulant, as are some of the other ones like Plavix. But if you can figure out initially which dose of warfarin is better for that individual based on its genetics, that’s a good thing.

Warfarin tends to be used when a problem arises, like potentially a stent or you’ve got some sort of other issue that needs anticoagulation so you need to put them on warfarin immediately. I think that having a point of care warfarin test for pharmacogenetics is probably the way that that is going to go. Nobody wants to sit around and wait for a day for some sort of genetic test to come back before they put them on a drug like warfarin if they need it immediately, if they’ve got an embolic stroke or something like that; you’re just going to do it anyway.

[DAMIEN BLENKINSOPP]: Right. That kind of information is helpful to have it already pre-done. That is why – it’s pre-empting the need for genetic data on you. In some cases it’s worthwhile doing, right? Cancer…

[MICHAEL NOVA]: Yeah, and then the holy grail in a certain period of time it will be 500 dollars or a thousand dollars to get a whole genome sequence of all your genes, all your DNA. Then everybody gets it done, insurance will probably pay for it, and it just gets put in your record at birth. That’s probably where it’s going.

If you look at the long-term goal of getting everybody genetically tested, that’s probably where it’s going to end up. Then you’ll just pull down the information when you need it – it’s already in your file, it’s in your electronic health record. Does this patient respond to carbamazepine? Does he respond badly to warfarin? You’ll just know that because you’ll just drop down the information electronically.

(46:04)[DAMIEN BLENKINSOPP]: Great, thanks for that. One other thing you mentioned, which I’m sure is going to be interesting to some people, is the athletics aspect and the performance there. Have you got any specific examples of genes you’re looking at and reporting that are useful for training or changing/optimizing there?

[MICHAEL NOVA]: Yeah, there’s a lot of genetics on VO2 max. Some people tend to have a tendency to have a higher VO2 max than other people based on their genetics. How do you use that information in order to tailor your workouts? Maybe you’re one of these people that has a low VO2 max, maybe you need to do more X exercise than somebody that has a tendency to have a higher VO2 max. So there are genes around that.

There are genes around power and endurance: some people tend to be more power people, which means that they respond better to power athletics or power sports than people that are endurance runners. There are some pretty famous genes in that power area – actin is one of them and ACE and some other genes.

Then there are genes around exercise and insulin response, exercise and sugar response. Our panel covers a lot of these and gives you a broad snapshot of what potentially would be a better type of exercise for you than somebody else.

[DAMIEN BLENKINSOPP]: Right. so the type suggestions would be resistance training versus endurance aerobics, cardiovascular kind of work – these kinds of recommendations?

[MICHAEL NOVA]: Yeah, and then a sophisticated personal coach – we use an Equinox personal coach – uses that information to tailor what types of exercise regimes, along with their diet, potentially would be better, you’d get more response around than something else.

(47:43)[DAMIEN BLENKINSOPP]: Great, thank you. Where would you recommend someone look to learn more about personalized genomics? Are there specific books or presentations of the subject that you know are good resources to learn more about this?

[MICHAEL NOVA]: I think we have a couple of them on our website, pathway.com. There’s a lot of them out there. The University of Utah has a very comprehensive genetics database.

If you really want to get down to hardcore genetics, all the genes are listed in certain databases such as GeneMed and NIH has a database of all the genetics and all the genes, all the variants and what they mean.

You can Google in “Genetics textbook” and there’ll be 50 of them that come up. Hospital groups like the Mayo Clinic has a really good genetics site, Harvard’s got a good one, Stanford and UCSF, they’ve all got really good information on those websites about genetics.

[DAMIEN BLENKINSOPP]: Great, great, great, thanks. How could people best connect with you and learn more about you and your work? Are you on Twitter or are you active anywhere else?

[MICHAEL NOVA]: Yeah, people lob in stuff to me all the time. I figure my email is usually the best way to get hold of me, or Twitter – we have a Twitter account from Pathway Genomics. A lot of information gets disseminated through the usual media outlets.

[DAMIEN BLENKINSOPP]: Alright, great. Is there anyone besides yourself you would recommend to learn more about this, for personalized approaches, whether it be pharmacogenomics or anything else?

[MICHAEL NOVA]: There’s a lot of academic groups, every major university has somebody that’s doing it. I could certainly give you a list of…

[DAMIEN BLENKINSOPP]: It sounds pretty broad. I don’t know if there’s anyone more in the populous base, potentially working with big companies like IBM or doing some similar work, potentially different in some areas to you that would be of interest?

[MICHAEL NOVA]: One person that’s been pounding the genetics drum bag for a long time has been Eric Topol, you’re probably familiar with him. He’s one of the leaders in personalized and putting the consumer in charge of his own health care. That’s basically what we’re trying to do here from a number of different angles.

(49:46)[DAMIEN BLENKINSOPP]: Great, excellent. A couple of questions now just on your own personal approach and view of body data; what kind of things have you had tracked for yourself, whether it’s genes or other biomarkers or fitness activity trackers? What kind of things do you track on your own biology?

[MICHAEL NOVA]: I’ve had my genome completely sequenced, so I know as much about my own genome as probably is available. So in that respect, I know what’s good for me. Then I’ve certainly changed around my diet a little bit and the types of exercise that I do based on what my genetics have shown me.

I do wear one of these Fitbit tracking gadgets, and there’s a lot of them; there’s a lot of different types. Then I’m going to for sure use Panorama, this health care app that we’re going to come out with, because it will be integrated into your cell phone. You type in “What shall I do for my exercise today?” and it will tell you, “Based on your genetics or lab results X, Y, Z, you should do this. You’ve already done a thousand steps, you should do this now. You can eat this. There’s a store around the corner, you can buy it there.”

There’s a whole bunch of different parameters that I think will be very, very useful in terms of tracking where you won’t know what’s really happening. I think that’s another thing that users will like about Panorama is there’s not going to be a lot of input; you don’t have to do a food log.

Users don’t want to do that kind of thing. We live in 140 character world!

[DAMIEN BLENKINSOPP]: Yeah, there’s a burden to collecting information.

[MICHAEL NOVA]: There’s a total burden. That’s a very good word to use. There’s a total burden and we’re trying to make it very easy for it to be done automatically, so you feel as though you almost have a guardian angel on your shoulder, in some respects.

[DAMIEN BLENKINSOPP]: Are you integrating it with existing sources of information or are you just making the app very easy to integrate? A bit like Evernote, which you can upload all sorts of things into it.

[MICHAEL NOVA]: Yeah, it will be both. You’ll be able to take what you want, or we’ll go out and find it. We’ll go get your Fitbit data, we’ll go get your electronic health record, we’ll go get whatever lab result, provided we get permission from you to do it, obviously. There’s consent that’s going to be involved in this whole thing.

We’ll try and make that, as you said, that burden or that bar really low. We’ll make it very easy for you to get a very inexpensive genetic test through the application.

[DAMIEN BLENKINSOPP]: So you’ll be able to buy a Pathway genetic test through the app and it will get integrated automatically?

[MICHAEL NOVA]: Yeah, or anybody else’s genetic test. Whether you’ve got 23andMe’s; we’ll integrate that information in there.

[DAMIEN BLENKINSOPP]: Great, great. Okay last question – I always ask this of everyone – what would be your recommendation to someone trying to use some data, any kind of data, to make better decisions about their health?

[MICHAEL NOVA]: Knowledge when it comes to preventing things from happening and to changing your behavior when it’s based on real science is a very powerful thing. We hear that all the time – “Oh, that’s why I didn’t like X or Y. Now I know it’s not all my fault. Now I can change it and stick to some potential diet regime with a lot more confidence and I’m going to get a better outcome.”

So for us, knowledge is power in order to change behavior, and that’s the name of the game for a lot of us is trying to change your behavior. Because you have a lot of power to be able to do that. Giving the consumer more information about themselves is a very powerful thing.

[DAMIEN BLENKINSOPP]: Right. It’s like once someone understands something more clearly, it gives them more clarity, it gives them more confidence; it makes it a lot easier to keep that behavior on board.

[MICHAEL NOVA]: Right.

[DAMIEN BLENKINSOPP]: Well Michael, thank you so much for your time today. I really enjoyed the chat.

[MICHAEL NOVA]: My pleasure.

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When we think about health risk, and reducing it, most of us are thinking about cancer, heart disease and strokes.

Autoimmune and other chronic health conditions aren’t top of mind, because they don’t tend to get the same attention in the media – and have much smaller research budgets currently.

But if you look at the numbers you are statistically much more likely to face autoimmune problems in your lifetime than heart disease or cancer or stroke.

In the US at any one time it’s estimated there are 9 million cases of Cancer, 22 million of heart disease and between 23.5 to 50 million cases of autoimmune disease. (Source: National Institutes of Health, American Autoimmune Related Diseases Association)

Autoimmune disease is becoming a growing collection of diseases as researchers identify more and more diseases which have autoimmune mechanisms behind them. Diseases assumed to be included are big names like Alzheimers, Parkinsons and Arthritis to name the best known.

I’m guessing that you did not miss the ALS ice bucket challenge to raise awareness and funding for Amyotrophic Lateral Sclerosis. 30,000 people have this condition in the US, and its one of the diseases which most likely falls into that 50 million bracket. Because of the small numbers it took a viral campaign to bring attention to ALS – which most people haven’t heard of.

But if we came to understand autoimmune diseases having a common mechanism – like mitochondrial health, that could quickly change how we look at treating all of them.

Today’s guest is currently running clinical trials to evaluate the impact on autoimmune disease of a “simple nutrient dense” protocol – a protocol that enabled the researcher herself to recover from one of the worst autoimmune diseases – Multiple Sclerosis. The basis for her protocol was supporting recovery and repair of the mitochondria.

Dr. Terry Wahls was diagnosed with secondary-progressive multiple sclerosis in 2003. This is the irreversible form of MS and by 2007 the disease had progressed to the point that she was restricted to a wheelchair and unable to walk.

But in 2007 she turned her condition around, taking her first steps within 3 months, and riding a bike again before the end of the year. Hers is the only known recovery from Secondary Progressive MS, and has been based on insights she took from published research on mice mitochondrial health amongst other things.

Dr. Wahls is also now the author of the Amazon Bestseller: “The Wahls Protocol: How I beat Progressive MS Using Paleo Principles and Functional Medecine” which describes her protocol.

In this interview we dig into the details of her current clinical trial, some of the biomarkers she tracks, and her views on linking mitochondrial health to autoimmune and chronic disease, and how nutrient based treatments can work to heal these conditions.

The show notes, biomarkers, lab test and links to Terry Wahls and everything else mentioned are below. Enjoy!

itunes quantified body

Show Notes

  • Terry Wahls explains her degree of recovery as it stands today including remaining symptoms from Secondary Progressive Multiple Sclerosis and gives the context to this recovery, as she is the only known case
  • An overview of the clinical trails that Dr. Wahls has been leading, their current status of progress, the results and the research to be done as next steps
  • The broader range of autoimmune, neurological and chronic diseases that Dr. Wahls is treating with her protocol
  • The top areas Dr. Wahls is receiving positive feedback as to efficacy of her protocol – including Multiple Sclerosis, Parkinsons, and other autoimmune diseases
  • Improvements in quality of life and performance that healthy controls, such as the researchers working on the trials, have experienced with the Wahls protocol
  • An overview of the Wahls protocol and how it works
  • The methylation, epigenetic and mitochondrial mechanisms behind disease and why the symptoms vary so much despite having similar mechanisms behind them
  • The concept of “nutritional reserve” and how it can be a balancing act as you recover to keep this building (especially where travel is an aspect of your lifestyle)
  • How the Wahls protocol provides for many many times the RDA nutritional recommendations and why
  • The list of biomarkers Dr. Wahls uses in her clinic, in her clinical trials for research and for her own personal tracking.
  • Dr. Wahls’ view of the effective use of the various testing labs currently available considering economics and insights or useful information they can provide.

Biomarkers in this Episode

  • Serum Vitamin and Nutrients: Dr. Wahls uses standard blood vitamin and nutrient labs to follow her own progress. She likes to see the values in the top quartile (top 25% of reference range), and mentioned specifically the B vitamins, this would be including Vitamin B12 and Vitamin B9 for example.
  • In Dr. Wahls Clinic she uses:

  • Lipids (e.g. LDL, HDL, Triglycerides, Total Cholesterol): Markers of cholesterol are commonly used with primary docs.
  • Homocysteine: An indicator of inflammation and of how well your methylation processes are running. Dr. Wahls likes to see this acutely improve.
  • hs-CRP (High Sensitivity C-Reactive Protein): A predictor for heart disease, more pain with fibromyalgaia and Terry uses to track progress via lowering inflammation. Dr. Wahls likes to see this improve significantly by declining, and that it takes some time to decline.
  • HbA1C (Glycated Hemoglobin): A proxy measure of your average blood glucose levels over the last 3 months.
  • Fasting Glucose: A measure of your blood glucose in a fasted state.
  • Micro Systems Questionnaire: Dr. Wahls uses a very detailed list of symptoms to use like an index to watch with parents, and watch their progress (e.g. as the number of symptoms decline).
  • In Dr. Wahls Clinical Study for learning purposes she uses:

  • NutrEval from Genova Diagnositics: Vitamin and anti-oxidant levels in the cell, How well enzymes are performing in the krebs cycle and electron transport chain and the fats.
  • Urine Toxicology: Using a challenge like DMSA, Dr. Wahls looks at the presence of heavy metals in the body.
  • Microbiome: Tests that look at the biome of the gut and the ratios of different bacteria that are occupying it.

Lab Tests from this Episode

  • NutrEval: Dr. Wahls uses this specific test in her current clinical trial – at this stage primarily to see what patterns emerge.

Other Resources Mentioned in this Episode


Interview Transcript

Transcript - Click Here to Read
[Damien Blenkinsopp]: So, Dr. Wahls, you had a diagnosis of secondary progressive multiple sclerosis, which is worst case, as I understand it. Could you explain briefly about what that diagnosis means?

[Dr. Terry Wahls]: Most people, I would say 80% of the folks with multiple sclerosis, are diagnosed with relapsing Multiple Sclerosis. And in that case there is an episodic worsening disease called the relapse, and improvement, called a remission. Most people’s relapse will be well within 15 years, and convert to secondary progressive.

So they have no more spontaneous improvement, they simply are experiencing the gradual sudden decline. In my case I was diagnosed in 2000 but within three years I had already transitioned to that steady decline and was in that secondary progressive phase.

[Damien Blenkinsopp]: All right, so in a typical situation is there any remission from the secondary progressive stage?

[Dr. Terry Wahls]: I don’t believe any have been reported other than mine in the scientific literature. There are some books talking about improvements, but if you are looking for a case report I am on the only one who has reported an improvement like that.

[Damien Blenkinsopp]: Great, so do you consider yourself in remission today? What remaining kind of symptoms do you have?

[Dr. Terry Wahls]: I am very clear that this is not a remission because this is not in a disease phase that has remission. The fact that I have improved to such a dramatic degree really means that the current understanding for multiple sclerosis has some gaps in it because this would be considered not possible. We have done clinical trials to show that in fact this level of improved function appears to be quite possible in others as well, not just me.

[Damien Blenkinsopp]: So today what symptoms do you still have? Or do you have any?

[Dr. Terry Wahls]: I am not as strong as a 58-year-old woman my age, so I can stand easily to give a lecture for an hour but if you ask me to stand for two hours that would be difficult. That is still fatiguing. I can go out and jog a mile and a half because I am continuing to improve. I have faith that will continue to improve.

My strength continues to improve remarkably but it is probably not quite as strong as you would expect for a normal, fully-healthy, athletic, 58-year-old woman. I want to stress the key point that I am continuing to steadily improve.

[Damien Blenkinsopp]: Great, that’s great to hear. I am very glad to hear that. What are the areas that you are targeting? You just mentioned your clinical trials. What are they targeting? I heard one explanation around your latest study was clinical trials are to prove the effectiveness of a nutrient-dense Paleo diet to reduce autoimmune disease symptoms. Is that kind of the best definition?

[Dr. Terry Wahls]: Actually, that’s really pretty close. I am very interested in diet and lifestyle and I studied that for traumatic brain injury and I am studying that for multiple sclerosis. We are writing grants to study it in other disease states as well, such as fibromyalgia and Parkinson’s disease. So we will see if we can get other people interested in funding it as well.

[Damien Blenkinsopp]: Great, great. So right now it is very multiple sclerosis-focused?

[Dr. Terry Wahls]: Right, so that is where I have the relationship and the funding sources, with a foundation that is particularly interested in multiple sclerosis-related research.

[Damien Blenkinsopp]: So the first study, the pilot study, was about 20 people. Could you give a very quick update on where your studies were?

[Dr. Terry Wahls]: Yeah we had initial funding to study 20 people using the diet, some targeted vitamins, meditative practice, exercise, and electrical stimulation of muscles. Because this was such a radically new concept the institutional review board, which is the safety committee that monitors research, told us that we can enroll ten, run the study with the ten, give them safety data, and then come back and enroll the second ten.

So we have published our results from the first ten that we got enrolled and that came out in the Journal of Alternative and Complementary Medicine. And the big challenge was finding other scientists who felt comfortable reviewing an intervention that was so broad-based, so that took a bit of time to find the appropriate reviews.

[Damien Blenkinsopp]: Okay, because normally they are trying to control the variables so it is changing one thing, but you have got many interventions stacked together there.

[Dr. Terry Wahls]: Right, and that is a very unusual study design. We were really testing with good people to implement the same, very complex regimen that I did and could it be done safely. It is called the safety feasibility study. So we want to know that people can do it and that you don’t hurt anyone. Because these are small studies all you are really hoping for is to have a trend in a favorable direction because it is [inaudible 00:09:23].

[Damien Blenkinsopp]: Okay, great. and you have another study underway now. Could you talk a little bit about that one?

[Dr. Terry Wahls]: Yes, so we have actually a couple of studies I am involved with. Because the first study used diet, vitamins, meditation exercise [inaudible – 00:09:43] and we wanted to begin to break apart the study to see how important those race components were.

So i have one study that is looking just at the exercise [inaudible 00:09:53] portion of the intervention and another study that we’re recruiting furiously for right now – which is a diet and lifestyle intervention where we are really just focusing on teaching them a Paleo diet that has been structured in a very specific way to maximize nutrient density.

[Damien Blenkinsopp]: So kind of summarize what the Wahls protocol is – how would you summarize it? Is it 80% nutrient?

[Dr. Terry Wahls]: This is really very intense nutrition. I stress vegetables, green leafy vegetables, sulfur-rich vegetables from the cabbage, onion, and mushroom family, and deeply colored. So if you’re a guy or you’re a very tall lady, that is 9 cups a day. If you are petite it is going to be much smaller, perhaps in the 4-6 cup range.

And the protein is sufficient protein, like 6 to 12 ounces of meat a day. And in the first level we can do it for vegetarians and vegans then as we advance I have some additional requirements to then move the diet to a more ketogenic diet for the more advanced person.

[Damien Blenkinsopp]: In terms of advanced do you mean people who are dealing with the worst severity of symptoms or as they get used to compliance and getting used to it?

[Dr. Terry Wahls]: Well we are testing in my clinical trial to see if the ketogenic version is more defective that the standard Wahls version, so I don’t have the answer yet. In my book I talk about why ketogenic diets may be beneficial and the research that is going on in the ketogenic diet around seizures, chronic headaches, schizophrenia, Parkinson’s, and my research in MS – there is also a lot of research with cancer and ketogenic diets.

This is a very exciting area and it may be another decade before we have the full answer, but I am thinking for those who are highly motivated, highly interested in a ketogenic diets, there are health benefits. I talk about the potential risks of a ketogenic diet as well. So it gets much, much harder to maintain really excellent nutrition while in ketosis over the long term.

[Damien Blenkinsopp]: Is that because you are limited in the vegetables you can eat?

[Dr. Terry Wahls]: Yes, absolutely.

[Damien Blenkinsopp]: Okay, great. So talking about your book a bit, the Wahls protocol is positioned a bit more broadly than just multiple sclerosis. Can you talk about who you are aiming at with the world’s protocol and the book?

[Dr. Terry Wahls]: So what i have discovered in my clinics time and time again is that by using the Wahls protocol to restore the health of the cell, the health of the person over the next three years steadily improves. They often need fewer and fewer drugs. The weight falls off without being hungry, blood sugars, blood pressures normalize often to the point where no medication is needed.

The most immediate people who are going to benefit are the folks with autoimmunity or folks with a lot of pain and the docs can’t make a diagnosis. But we’re also observing that people with medical problems requiring medication often find that their medication needs steadily decline. the mental health problems also often steadily improve – anxiety, depression, irritability, focus, autism, and other neurological disorders.

We have many, many folks with Parkinson’s who have reached out to say that their symptoms do not include [inaudible – 00:13:38] and of course the folks with MS who are telling us how much they have improved as well.

[Damien Blenkinsopp]: Right, so that was my next question – where are you getting the most feedback in society as you spread the Wahls protocol and the word about it? Which areas have you heard the most feedback from people that have these positive results?

[Dr. Terry Wahls]: Multiple sclerosis and then Parkinson’s probably next. Diabetes would be probably third and then fourth I would say I have so many folks with a wide variety of autoimmune problems that are telling us that symptoms have been markedly reduced. Many of these autoimmune diseases I have not encountered before so it just lets you know about the diversity of autoimmune problems with inflammatory bowel disease, psoriasis –

[Damien Blenkinsopp]: There are like over 160 classified –

[Dr. Terry Wahls]: Yeah, and we keep adding many, many more every years. I would not be surprised if in the next two decades we begin to rethink our autoimmunity to the point where it is a matter of nearly every chronic disease having some level of autoimmune component. That is my prediction but we will see if that turns out to be the case.

[Damien Blenkinsopp]: That is very interesting. So moving kind of away from health issues and also a bit more generally, on Dave Asprey’s Bulletproof Radio you mention that some of your research staff have been using the protocol and I think also they also followed the protocol so that they understand it and while they are all healthy they have noted some positive impacts as well.

[Dr. Terry Wahls]: Yeah, actually it’s really interesting. So students come volunteer in my lab and I ask them to fill out the forms and follow the diet for a couple of weeks just so they get a sense of what our subjects have to do. So these young kids are healthy, robust, and we think at the peak of their game and they nearly always discover that their attention improves, concentration, memory, sleep, and mood improves.

Several kids had their chronic headaches go away. And a couple others realized that some of their family’s health issues could be addressed by diet and lifestyle and this had a really nice favorable impact on their extended family.

[Damien Blenkinsopp]: That’s great to hear. We have been talking a lot about acute conditions before but in terms of long term disease prevention, risks, aging, and potentially talking about cognitive performance, improvements, less headaches, and so on, do you think there is a lot of application for these areas as well, beyond the acute illness and where it started from?

[Dr. Terry Wahls]: This will be very beneficial for chronic health problems. Certainly in my book I talk about autoimmunity a great deal and then I acknowledge that my other medical issues that we don’t think of traditionally as autoimmune also seem to be dramatically helped with weight issues, diabetes, high blood pressure, cholesterol problems, mental health, and the traumatic brain injuries that I followup and take care of.

[Damien Blenkinsopp]: That’s a very broad area. In term sof the areas you see it positively impacting, are there any similarities of the issues? What are the underlying mechanics? Like the way that you are looking at it today, how that is being addressed?

[Dr. Terry Wahls]: I am looking at the health of the cells and the effectiveness of the mitochondria. And so I am looking at the nutritional needs of the cell and how to provide them using food, because I think food is safer than supplements and probably much more effective. And so with just the mitochondria you need basically all the B vitamins and you are going to need minerals, magnesium, zinc, and sulphur.

You need a lot of fats, the omega-3 and omega-6 fats, the saturated fats, cholesterol fats, to make healthy membranes. Then you have to protect the mitochondria so things like zinc, mercury, and lead, and some of the [inaudible 00:17:51] that we take a lot of, like antibiotics, which are tough on our mitochondria. And by maximizing cellular nutrition then we start much more effectively having our epigenetics factor set.

We have basically more efficiency in all of the biochemical processes in ourselves, which over time will lead to healthier organs and of course a healthier person. Some things go away very quickly like the fatigue and the brain fog. Often that is dramatically better within 12 weeks. Things where you have to replace or rebuild proteins that may take one to seven years, depending on what organ in the body you are trying to rebuild.

[Damien Blenkinsopp]: Right, so do you have a theory as to why are mitochondria behind autoimmune disease? There is a whole variety of issues taking place in the body. Do you have some kind of underlying mechanism as to how this works and how the damage is caused to the mitochondria in the first place?

[Dr. Terry Wahls]: Well I think there are many, many reasons our mitochondria can get damaged. The toxic load that we are all exposed to continues to climb every year and many of these toxins will have negative impacts on some of the proteins involved in the mitochondria and how the mitochondria manages the electron transport chain. So that is one problem, straight up. Just direct toxic effects for mitochondria.

These toxins in addition to the direct toxic effects will interact with the DNA, putting adducts on the DNA, and causing certain parts of our DNA to be read and other parts to be silenced and not read, so that shifts how my DNA would have been read by the presence of these toxins. And that changes our biochemistry.

[Damien Blenkinsopp]: Are you referring to – is that working for methylation processes?

[Dr. Terry Wahls]: Methylation is one of the processes and I will also predict that we don’t really understand all the ways that epigenetics impact their DNA. Methylation is one way and changing the histone protein is another way. And we may find that there are even additional ways that we have not yet unraveled.

But clearly toxins are interacting with our DNA, turning genes on and off without changing the actual DNA sequence. So we have lots of toxins that are doing this. And some of those toxins, by the way, include the drugs that we take and the antibiotics and the things that have gotten into our groundwater. And of course all the food and indoor environments, etc.

[Damien Blenkinsopp]: Great, so in terms of I think for people at home to understand, it is like if the mitochondria are behind the problems you are encountering, why is there such a wide different variety of conditions, such as Parkinsons?

[Dr. Terry Wahls]: You know, that is really something I talked about in my book and that conventional medicine, over 100 generations of stuff. We have been classifying diseases based on the history, the symptoms, physical exam, and then more recently laboratory testing. And we did all of that before we understood the molecular basis, how these diseases evolve.

But what is startling to physicians and scientists, and medical students as well. Now that we begin to understand the molecular basis of these diseases, with what is going on at the molecular level, the cellular level, we are seeing that the diseases look more and more alike. There is often inappropriate inflammation of the body attacking itself or having too many inflammation molecules.

We have mitochondria that are not generating energy appropriately with too many free radicals being generated, causing early aging. We often have a sense of excessive toxic exposure and toxins are stored in the fats and in the tissues. We’re seeing the production of inflammatory molecules.

We often have problems with the gut with the wrong bacteria mix living in our bowels, created a leaky gut and allowing for contents within the bowels to slip into the bloodstream and bringing it along with them for some bacterial protocols with incompletely digested foods, all of which will create more inflammation in the body. What is so startling is we see those same core abnormalities whether or not the person has schizophrenia, depression, diabetes, MS, chronic fatigue, fibromyalgia.

We see a slightly different mix but those same, less-effective cellular processes are present to varying degrees in nearly every chronic medical problem, mental health problem, neurological problem, or autoimmune problem.

[Damien Blenkinsopp]: Yeah, do you think that the pattern that shows up in each person is probably down to genetics and epigenetics?

[Dr. Terry Wahls]: Well actually the pattern is maybe 5% or less epigenetics. The rest, the 95%, is due to the environment, and that includes diet, activity level, toxic exposure, and stress level, probably as the big four. Then infection, exposures, family relationships, social bonding, social networks, and all of that will interact probably through the person’s epigenetics to some degree directly to toxins in the cells and nutritional deficiencies to the cells themselves is another thing.

All of those are factors and because we’re all unique with our unique DNA, so even if i had a twin sister and we share the same DNA and we grew up in the same house we would still have differences in our environment and it would be enough to affect those genetics slightly differently and to create a different health status for both those individuals.

[Damien Blenkinsopp]: Right, another thing I think is interested is – I was diagnosed with chronic fatigue syndrome and one of the first things I was looking at was MS – multiple sclerosis – because I had difficulty walking and a symptoms list which kind of fits with that at first. As you were talking about it already, you are talking about the list of symptoms as a diagnosis but it can be very difficult to judge based on symptoms.

I think there are a lot of diseases which we have in categories which often have a list of very similar symptoms and the differential diagnosis isn’t being made in a lot of the cases and it is kind of a fuzzy line at the moment. So do you think instead of my presentation here which is potentially I have something which is chronic fatigue/MS, where I had that, and then somebody else has maybe 100% MS is the classification. And there are all these mixes out there but they are getting split into different categories based on who looks at it.

[Dr. Terry Wahls]: You know, one of the things I’m observing is that [inaudible 00:25:41] Clinic, where we treat people with chronic health problems and they can be mental health problems, physical problems and the big thing that they have to do is agree to the diet and the lifestyle, and [inaudible 00:25:53] for them.

And what I find is I am less and less interested in the names of their diseases and much more interested in diagnosing all their environmental factors addressing those. And I will use the same types of interventions across many disease states and I find that to me the most important thing I need to know is diagnosing their diet and lifestyle choices and exposures that they are doing and helping them address those. my young students are intrigued that my approach is so different to what they were taught. And it appears so remarkably effective, although making the diagnosis is far less important than understanding a person’s diet and lifestyle issues and diagnosing that.

[Damien Blenkinsopp]: Right, that is very interesting because then you can look at the weakest areas of someone’s lifestyle, if you have a blueprint for a more ideal lifestyle.

[Dr. Terry Wahls]: Oh yeah, and you have to work with them, work with their family, have them evolve this collaboratively. So if you are in my trial you have to evolve in one fell swoop in the trial, but if you’re in my clinic we negotiate with people to adopt these concepts at the pace they are willing to live with.

[Damien Blenkinsopp]: Yeah, because compliance can be an issue with a lot of these diets. So just going over the Wahls protocol in a bit more detail, there are some things that you want to remove? Can you talk quickly about the items you want to remove from a diet and why?

[Dr. Terry Wahls]: Well I look at what are the foods that at least in Westernized society are most likely to cause abnormal immune response and the top on is gluten-containing grains, the wheat, rye, and barley as most common. But many of the ancient grains have gluten so it is not – you want to reduce those gluten grains because the gluten and dairy overlap and you also take away all the dairy proteins, so we take out dairy as well.

And because the third most common is eggs we take out eggs and then in my book I give people directions on how to take out the next level of problems if that more simple approach doesn’t resolve things for them.

[Damien Blenkinsopp]: Yeah, so is that just [inaudible 00:28:20] or are there other items as well? Does it get more complex than that?

[Dr. Terry Wahls]: That’s the top three and then it’s a much more sophisticated conversation about what else to consider. And I am really very reluctant – some of the Paleo authors give people a very detailed elimination diet but from my perspective you are just increasing the risk of micronutrient deficiency when you have an excellent probability that just taking those three out would have a dramatic, favorable impact.

Now, if it doesn’t then you may need to go through a more comprehensive elimination diet in a step-wise fashion. That’s the approach that I am more comfortable with and I have had marvelous success.

[Damien Blenkinsopp]: Have you seen – because you emphasized it is pretty much a heavy intake of micronutrients in terms of the variety and the [inaudible 00:29:16]?

[Dr. Terry Wahls]: Oh yeah, and the rationale for that is I am a very simplistic thinker. So when I look at the literature I see the traditional society is still eating the traditional foods, traditional lifestyle, and eat radically different things in each locale but what is consistent is there is an extraordinary micronutrient density of vitamins, minerals, and fats per calorie.

Now, there is a huge variety in what the percent of fat, protein, and carb is across the various localities. So my interpretation of that data is that our mitochondria are actually quite flexible. They can burn sugar, fat, or protein and get energy for us to run the chemistry of life. But it appears that our ancestors identified what foods would give you the highest micronutrient density.

Sometimes it was going to be a fat-based diet, sometimes it was a protein-based diet, and sometimes it is a carbohydrate-based diet. So I then went around and used science to help me figure out what were these key micronutrients I could track as I designed my diet. So now we have 36 that we track and then I designed a diet using foods that I could get through agricultural means that would give me the various antibiotics, vitamins, minerals, and fats that science says my brain needs.

And once I redid my diet like that it was dramatic – within three months my fatigue was gone and I clearly was beginning to recover.

[Damien Blenkinsopp]: About your recovery, one of the things I heard you mention before is nutritional reserve and how at the beginning you would have something like a 36-hour crash window if you weren’t continuing to take in the amount of nutrients that you are currently doing.

[Dr. Terry Wahls]: Yeah, and now in retrospect I think in the first two years or even three years from my recovery is as I was improving I still hadn’t had enough recovery yet so that when I traveled, because I was now having enough energy to travel again, that my vegetable intake dropped and then my fatigue would come back, my brain fog would come back, and I would be craving greens. So I would come home to this huge salad bowl of greens which I would immediately scarf and begin feeling better.

[Damien Blenkinsopp]: Just out of interest, how long would it take you to feel better?

[Dr. Terry Wahls]: About 24 hours – actually probably 12, because I would eat that after I got home that night from my flight and then by morning my thinking was more clear and my energy was back up. And then I began to travel with a head of cabbage because that travels easily and you don’t need to refrigerate it.

I would just consume that and it seemed to work pretty well. Now I am well enough that I don’t need to travel with food, so if my vegetable function dips for a couple of days or a weekend that doesn’t bother me now. Again, because I think I have so flooded myself with nutrition that they just have a lot more reserve than they had before.

[Damien Blenkinsopp]: That is great – so the first 20 or 30 years of your life and you didn’t have multiple sclerosis, do you think eventually if you built up enough nutritional reserve you could walk around for a week – I imagine that in your 20s most people weren’t eating an ideal diet and you can eat that kind of thing, or do you think there is no way, like once you have had some kind of condition you already have to be very compliant with this for the rest of your life if you want to keep symptoms at bay?

[Dr. Terry Wahls]: Those are great questions. My observations from our clinical trial is if you deviate from the protocol you lose ground. If you go back to giving yourself substandard nutritional support and things will begin to decline and you will end up with more rapid aging and probably more diffuse symptoms.

[Damien Blenkinsopp]: All right – in terms of how much we’re talking about here, if we think about someone who has got a typical modern diet and someone else who has got a typical kind of Paleo diet, how much more vegetables are they eating every day?

[Dr. Terry Wahls]: Well when people come in – and I am trying to give this to you from memory here – and I believe that based on fruit and vegetable intake it was one-and-a-half servings a day. At 12 months the typical intake was seven-and-a-half. And most of our people are women and we just had a couple of guys so they were really doing an extraordinary amount of fruits and vegetables.

My nutrition colleagues told me that in the nutrition science world if you get someone to shift their vegetable intake just one serving up a day that is considered a phenomenal success. And for us to have shifted the vegetable intake from one-and-a-half up six more cups, she is thinking it was unheard of and no one had been able to do that previously.

[Damien Blenkinsopp]: Yeah, that’s pretty impressive and there are more benefits for the people on these trials than the average I guess. In terms of recommended daily amounts you are far exceeding the nutrition values of recommended daily amounts. What do you think about the recommended daily amounts of the vitamins and so on? Do you think they are sufficient for everyone and sufficient for some people?

[Dr. Terry Wahls]: Likely not because they are designed to prevent you from going into an acutely diseased state associated with that particular vitamin or mineral. So we will take, for example, vitamin C. They set a level to prevent you from acquiring scurvy, which is vitamin C deficiency.

But we don’t know what level is required for optimal health, which might be 50% more or 500% more, but I think what might be a more valid way of thinking about this would be if we looked at what were the RDAs that people hit who were eating traditional foods, traditional diets, and traditional societies, that likely those societies over time that figured out how to get these micronutrients for optimal health.

And when we use those values the intakes are two-to-ten-fold above the RDA depending on the nutrients. And actually that was one of my goals, to get my nutritional analysis pattern to look like hunter-gatherer societies to get two-to-ten-fold and we get two or maybe eight-and-a-half fold. We are very pleased.

[Damien Blenkinsopp]: And so from the safety standpoint of your pilot study, one of the ideas was to see if you are doing 1000% RDA?

[Dr. Terry Wahls]: We get as high as eight-and-a-half times the RDA from food. And again it looks very much like the hunter-gatherer societies. The biggest side effect was if you are overweight or obese you lost weight without being hungry and got back to a healthy diet again.

[Damien Blenkinsopp]: Okay, and there were no toxic issues at all?

[Dr. Terry Wahls]: No toxic issues. Some people had – some of the vitamins had some GI upset, some nausea. And we told them that if anything seemed to bother you just to skip it. So they did and we had a few people who couldn’t eat as many greens as we advocated so they just titrated down to what their tummies would agree to.

[Damien Blenkinsopp]: But I guess that would be down to like the ability to process – ?

[Dr. Terry Wahls]: Well that’s right. It’s microbial, it’s deficiencies of their own particular enzymes, so there is probably a combination of who have got living in the bowels and what was the efficiency of the set of enzymes that you have that you are born with. And it would seem that some people do not metabolize sulphur quite as well so they need either more sulphur or less sulphur in their diet and how their enzymes are working.

[Damien Blenkinsopp]: Right, I think some people have – I think I have a partial issue with this, detoxification of sulphur. So too much sulphur can cause issues because you have to detoxify it as well.

[Dr. Terry Wahls]: We are all unique. And I stress that in my book, that we are all unique. I have got a public health message out here that will be good for everyone, but I certainly can’t guarantee it will be good for an individual so they have to really pay attention to how well they feel on this and work with their personal stock because they definitely may need things adjusted because of their unique DNA and unique health issues.

[Damien Blenkinsopp]: So which types of biomarkers are you looking at when you are tracking this data and you are in the clinical trials?

[Dr. Terry Wahls]: It was divided into two questions in my clinical practice. We don’t do any fancy functional medicine testing. We do things that primary care docs will feel very comfortable using – lipids, glucose, hemoglobin A1c, B12, folate, C-reactive proteins, and homocysteine levels. Primary care docs should feel comfortable looking at that stuff. In my clinical trial we are doing things just to see how they change over time and I am not changing my protocol based on these results.

We are just trying to learn the mechanisms of what is going on. So we measure things like who and what is growing in the poop for microbial analysis, what heavy metals are showing up in the urine, so that is the toxicology. And that is done with a very mild kelator. Then I do a nutri-eval, which is by Genova Diagnostics, which gives me a detailed look at the vitamins and antioxidant levels within the cells, a really nice look at the generation of HET to the mitochondrial electron transport chain and how well that’s working.

It gives a nice look at the fats and how the fat metabolism is working and making the long chain fatty acids or arachidonic acids, [inaudible 00:40:01] acids. We get lots of detail that we will be able to use to write up our papers and project why we have these very lovely results that we’re seeing.

So that’s fun research stuff. It is not what I am doing in clinic and in clinic what I am finding is careful history, a thoughtful exam, and some very simple labs like primary care docs get a lot of the time.

[Damien Blenkinsopp]: Because you are working with patients who are working with other people so you are talking about the language here that you are enabling the patient by using language that they can talk to with other people easily?

[Dr. Terry Wahls]: Yes. So we want to address that lifestyle. We want to have some guidance. I do use these labs. You need to think about functional medicine things but you don’t have to spend tens of thousands of dollars for functional medicine assessments. You could just address all the lifestyle stuff very thoughtfully and very comprehensively, get someone to do a thoughtful history for you and I would say there is probably a 90% probability that your health will steadily improve as a consequence of those actions.

[Damien Blenkinsopp]: And you would be tracking that based on symptoms and how the patient feels?

[Dr. Terry Wahls]: Yeah, the most sensitive ritual that we have is what we call the medical symptoms questionnaire which I have got in my book. It’s a detailed list of questions asking about how your eyes and ears and nose – it goes through your entire organ system and you can get scores from zero to I think almost 300 points if everything is not working.

So that is a very nice way to look if the chemistry of all of your organs are working well or if there is some level of problem. And that is the best number for us to track with how well people are doing and how well we are doing for them.

[Damien Blenkinsopp]: Great. In terms of – like, you mentioned some things and everyone accepts today the chronic headache pains for example. Would you consider that as a condition, a symptom that shouldn’t be there?

[Dr. Terry Wahls]: Absolutely. And again, I have many people with chronic headache pains and we get them to address the diet and lifestyle issues. And those headaches finally resolved.

[Damien Blenkinsopp]: So amongst all the blood tests you have mentioned and you said they use them because it is easier to talk with our primary care doctors, do any of them ever stand out as interesting? You mentioned the symptoms list is actually the most interesting. But you mentioned inflammation markers, homocysteine -?

[Dr. Terry Wahls]: Well homocysteine and CRP are acutely – I would like to see those improve. That tells me there is too much inflammation or the brain can’t metabolize the vitamins very well. And then the hemoglobin A1c lets me know how many carbs they are eating, how much insulin they have to use, and trying to get that number lower and lower. That takes a little bit more time but again that is a very helpful intervention to follow.

[Damien Blenkinsopp]: Great so CRP, as far as I understand it that isn’t really related so much to autoimmunity. That would be more related to dietary inflammation?

[Dr. Terry Wahls]: And again I predict that in ten more years we are going to overlap that together. More and more disease states we are recognizing. If your C-reactive protein is elevated you have too much inflammation in the body and that is a predictor for worse heart disease, worse risk for stroke, more pain with your fibromyalgia, so it is an independent risk factor and if we get people on nine cups of vegetables a day, get rid of the gluten and dairy, that CRP will typically fall.

[Damien Blenkinsopp]: Okay, because I guess your protocol is so nutrition based, in terms of the tests you are doing I think it is mostly nutribalance and blood plasma tests for vitamins – what interesting things have you seen in terms of nutritional status? Have you seen any patterns in the people you get where it is showing up that their nutrient status is very low or with different patterns?

I spoke recently with William J. Walsh. He has worked with brain neurology for many years and he found some nutritional deficiencies were driving or often contributing to symptoms of schizophrenia or other diseases and correcting those would help them. So I am just wondering to what extent you might have seen some kind of patterns where specific nutrients are showing up a lot?

[Dr. Terry Wahls]: Those analyses are ongoing right now and I can’t comment yet.

[Damien Blenkinsopp]: Okay, no problem. If you were looking at – because we spoke a lot about mitochondria and what the status of those are and if you wanted to understand from a more testing standpoint the status of the mitochondria. Are there any particular tests you would look at with the nutrival test or any others that would be useful to understand what is going on with the mitochondria?

[Dr. Terry Wahls]: Nutrival is certainly one that I would use. Several of these functional labs have tests and use the nutrival, that can give you insights into how well the enzymes are performing at every step of the electron transport chain and the Kreb’s cycle. That can be very helpful to follow that over time and then provide nutritional support and free enzymatic steps that appear to be blocked.

And that would just – order the nutrival and follow those guides along. But again I remind your listeners that one can do that if they have had diet and lifestyle interventions very effectively for a year and haven’t gotten where they want to be. These tests are extraordinarily expensive and you follow them all the time and it is a $1000 to a $1500 excess, so it is not cheap. So from my experience at the VA I frankly don’t think it is clinically necessary for the vast majority of people.

[Damien Blenkinsopp]: Right, but for you it is more interesting to basically do a project and say I am going to use this protocol for six months and see what happens in terms of symptoms rather than doing tests to figure it out.

[Dr. Terry Wahls]: That would be my preference and I would certainly still work with the primary care doctor and have that basic primary care testing to help guide and refine things a bit. But I don’t think that it is – rarely do you need to spend $20,000 to $30,000 on testing to understand the mechanisms of why diet and lifestyle will make you better.

And that is what functional medicine testing does, it gives you the mechanism to explain why you should make these interventions and why they are going to help you. Or you could just make all the interventions to begin with and see if that would help. And then if it doesn’t then yes, you may need to spend a lot more money for a very thoughtful, functional medicine [inaudible 00:47:17]. But yeah, unless you have a lot of money to burn, try to do diet and lifestyle first.

[Damien Blenkinsopp]: Right, it sounds like a lot of these tests – you don’t see the value in them for most cases and it is better to spend some time and some money on the actual protocol as a test rather than spend the money on these tests which are currently a lot more expensive. You said the primary care tests are a lot more general?

[Dr. Terry Wahls]: Well you can easily spend $30,000 if you run down the functional medicine testing to understand everything that is potentially [inaudible 00:47:50] wrong with you. I think it is not money well spent for the vast majority of folks.

[Damien Blenkinsopp]: I see. One thing we didn’t look at but I heard you mention before is one of the issues you see with the mitochondria is membrane fluid – what is the issue around that?

[Dr. Terry Wahls]: Well it was probably in the 70s where we had a public health campaign against butter. You are also not supposed to use margarine with a lot of trans fats in it. And we have flipped out the beef with the deep fryers and fast food, and lard for vegetable oil, which increases the risk of trans fats. So our trans fat intake soared – and we all felt that was a good thing for us.

Now we realize trans fats are very rigid. They stop the fluidity of the membranes and it accelerates aging. It accelerates the risk for heart disease, cancer, dementia, and other neuroregenerative processes. Somehow after World War II we developed the fat theory for clogging of the arteries and then fat became demonized and so we switched to this low-fat diet but on a low-fat diet you don’t get enough of the fats that our membranes need to keep things nice and flexible and keep things fluid.

So you cannot have the bad fats, which are trans fats, vegetable oils that are heated, and you want to avoid those.

[Damien Blenkinsopp]: Have you looked at, I think it is called lipid exchange, where you purposely try to take in more fats and more fats of different types in order to promote – is that something that you have figured into your diet in terms of the fat intake?

[Dr. Terry Wahls]: We talked about fat at great lengths in the book and as I put people into ketosis we definitely increase the fats and have opinions about which fats they shoudl be eating, absolutely.

[Damien Blenkinsopp]: Another thing you mentioned earlier is supplements versus food. I know you are a proponent more of food, but you did take supplements to start with?

[Dr. Terry Wahls]: Yeah, I took supplements and they slowed my decline – they did not lead to recovery. When they added more supplements in the functional medicine folks that leveled things out and when I redid my diet is when I began to recover. So supplements targeted in a very, very thoughtful way may be useful but it is very difficult to have a big public health statement saying, ‘These are the supplements you ought to take.’ It really should be individualized based on that person’s story and their current health status.

[Damien Blenkinsopp]: Right. And you mentioned safety of supplements – what is your concern?

[Dr. Terry Wahls]: Well most of them are made in China now so I think people need to remember that and many of the supplements are made by genetically-modified bacteria. They do it, think about that as well.

[Damien Blenkinsopp]: Well I have lived in China and I have read the news a lot there so I can attest to the supplements used there.

[Dr. Terry Wahls]: Yeah, so they may be useful but you really have to think carefully about how useful they are.

[Damien Blenkinsopp]: And in terms of economics, I know some of the extremes for you guys and I think you actually grow some of the food in your back garden. Can you talk a little bit about the economics of you are a proponent of organics versus conventional? In terms of the economics of food, is it a lot more expensive?

[Dr. Terry Wahls]: I am going to vigorously disagree with this. I think the problem is people want someone else to cook the food and when you have someone else cook the food it is going to cost you more versus you buying the ingredients and cooking it yourself. And we have a number of lovely articles in the New York Times and I compared that – that are going to fast food restaurants and they cook the food versus you buy it and make it yourself. It is always cheaper to buy it yourself.

Now, if you want to go organic and grass-fed, which does have more health benefits, yes, that does become more expensive. But you can eat vegetables, clean protein, ditch the glutens, sugar, and processed foods for less if you cook it at home than if you are getting either fast food or something that corporate America has cooked for you.

So I like to see people go organic and get grass-fed if their monetary means allows that. You can still recover just eating more vegetables in the pattern that I have described. It will take you longer to clear all the toxins than if you were able to go grass-fed and organic. So you will begin to heal but it will take longer.

[Damien Blenkinsopp]: Right, now that is very – it is not yet proven by research. Is that something you are going to look at, the split of conventional processed – ?

[Dr. Terry Wahls]: That will be a wonderful project for us to do. We will see if we can get someone to pay for it.

[Damien Blenkinsopp]: Yeah, I bet you have got many projects in your head that you would like to do soon. What do you think will happen in this whole area in the next five or ten years in the area of testing and biomarkers and things like – well, what interesting things would you like to be able to test for?

[Dr. Terry Wahls]: I think the public is going to race out rapidly ahead in probably the medical field. I think it will be interesting to see ultimately that we could do rapid genetic testing and tell you which enzymes that you have are less effective and perhaps which vitamins you need to stress, which foods to stress, which foods to avoid. That would be very interesting.

And likely there will be a time that we can do that and then what we could probably do would just be the swish, gargle, and spit it out into a cup and get a readout of recommended dietary choices, recommended vitamin supplements.

[Damien Blenkinsopp]: Do you think that will be available within the next ten years?

[Dr. Terry Wahls]: I have no idea. I have to warm you I have clinic in two minutes so we should be wrapping this up.

[Damien Blenkinsopp]: Yeah, nearly there – great, and thanks for your time. What comes next in your research? What are your sort of next steps that you are looking at? I understand that you are crowdfunding projects?

[Dr. Terry Wahls]: So as a matter of fact tomorrow I will be talking with someone about a project that we are thinking about and throwing it up for crowdfunding. So I am going to be learning about that. I am submitting a grant to the MS Society and that is why I am feeling a lot of time pressure today because that is due here in the next couple of days.

And this Fall it is very exciting to know that the national MS Society here in the US is convening a programming meeting to talk about research priorities and programming for diet, lifestyle, and wellness. And they asked me to be one of their experts. So I was very excited about that. I thought that was –

[Damien Blenkinsopp]: Well that is a big milestone for you. That is kind of where you started all this.

[Dr. Terry Wahls]: Yeah, that will be huge. That will be very exciting.

[Damien Blenkinsopp]: That’s great to hear. So if you were going to track some biometrics of your own on a routine basis or do you track any biometrics for yourself?

[Dr. Terry Wahls]: Well I like to know where my vitamin D is. I like my B-vitamin levels at the top quarter of the reference range. And in general I am looking for nutrient biomarkers and I prefer they are in the top quarter.

[Damien Blenkinsopp]: Are you using nutrival or some other test for that?

[Dr. Terry Wahls]: No, that’s too expensive. I just use the straight primary care labs that folks get for these vitamin levels.

[Damien Blenkinsopp]: That is just plasma levels?

[Dr. Terry Wahls]: Yeah.

[Damien Blenkinsopp]: Great, okay. Well Terry, thank you very much for your time today. I know you have got another meeting.

[Dr. Terry Wahls]: Send me the link to the interview when it is available and I will shoot it to my social media team as well.

[Damien Blenkinsopp]: Great, I will do. It will go up in about three weeks’ time – that is when we are launching it.

[Dr. Terry Wahls]: Thank you very much.

[Damien Blenkinsopp]: Good luck with your meeting.

[Dr. Terry Wahls]: Okay, bye now.

[Damien Blenkinsopp]: Bye.

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